The EU Clinical Trials Register currently displays
34922
clinical trials with a EudraCT protocol, of which
5688
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.

1- Histologically or cytologically confirmed breast cancer in women with radiographically confirmed metastases to the brain a. patient may have dural lesion(s) as the only site of disease in the brain, only if lesion(s) are pathologically confirmed to be malignant and proof of onset after primary diagnosis of breast cancer is available b. patient may have extracranial metastases c. patient may have received prior treatment for breast cancer and extracranial metastases d. patient may receive concurrent trastuzumab, hormonal and/or corticosteroid therapy2- At least 18 years of age3- KPS>=704- Adequate hematologic, hepatic and renal function: - hemoglobin >= 10 g/dL, white blood cell count >= 2.5*10^9 cells/L; absolute neutrophil count >= 1.5*10^9 cells/L; platelet count >= 100*10^9 cells/L; - total bilirubin <= 1.5 time the Upper Limit of Normal (ULN); aspartate aminotransferase and alanine aminotransferase <= 3 times ULN - serum creatinine <= 1.5 mg/dL; 5- Adequate pulmonary function tests by simple spirometry, as defined by forced vial capacity and forced expiratory volume in 1 second >+ 50% of normal for patient age, gender, height and race6- Resting arterial O2 saturation (SpO2) measured by cutaneous pulse oximetry (SpO2)>=90% while breathing room air7- Exercise (eg walking uninterrupted for approximately 15 metres on level ground) SpO2>=90% while breathing room air8- (criterion removed in protocol version 2.2)9- Women of childbearing potential must be practicing a medically acceptable contraceptive regimen and must have a negative serum pregnancy test within 14 days prior to first day of WBRT. Patients who are postmenopausal for at least 1 year (>12 months) or are surgically sterilized do not require this test10- Patient must be accessible for repeat dosing and follow-up11- Patient must give written informed consent

E.4

Principal exclusion criteria

1- Active concurrent malignancy (except nonmelanoma skin cancer or in situ carcinoma of the cervix). If there is a history of prior malignancy, the patient must be disease-free for>=5 years2- The patient is a candidate for surgical resection and/or stereotactic radiosurgery as initial therapy for brain metastases3- Planned concurrent systemic (cytotoxic and/or cytostatic) treatment for breast cancer and/or extracranial metastases during WBRT, with the exception of trastuzumab, hormonal and/or corticosteroid therapy4- Prior treatment for brain metastases (including external beam radiation therapy, brachytherapy, stereotactic radiosurgery, surgery, chemotherapy, and treatments with investigational drugs, biologics or devices)5- Presence of leptomeningeal metastases6- Use of any investigational drugs, biologics, or devices within 28 days prior to WBRT day 17- Previous exposure to efaproxiral8- Women who are pregnant or lactating9- Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment10- Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent

E.5 End points

E.5.1

Primary end point(s)

Survival, measured from the date of randomisation

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

No

E.6.2

Prophylaxis

No

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

No

E.6.7

Pharmacodynamic

No

E.6.8

Bioequivalence

No

E.6.9

Dose response

No

E.6.10

Pharmacogenetic

Information not present in EudraCT

E.6.11

Pharmacogenomic

No

E.6.12

Pharmacoeconomic

No

E.6.13

Others

No

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

No

E.7.1.1

First administration to humans

No

E.7.1.2

Bioequivalence study

No

E.7.1.3

Other

No

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

No

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

No

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

No

E.8.1.4

Double blind

No

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

No

E.8.1.7

Other

No

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

No

E.8.2.2

Placebo

No

E.8.2.3

Other

No

E.8.3

The trial involves single site in the Member State concerned

No

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.5

The trial involves multiple Member States

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Information not present in EudraCT

E.8.8

Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial

Once the 281st death has been observed

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

2

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

2

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

No

F.1.1.1

In Utero

No

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

No

F.1.1.3

Newborns (0-27 days)

No

F.1.1.4

Infants and toddlers (28 days-23 months)

No

F.1.1.5

Children (2-11years)

No

F.1.1.6

Adolescents (12-17 years)

No

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

No

F.3 Group of trial subjects

F.3.1

Healthy volunteers

No

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Information not present in EudraCT

F.3.3.1

Women of childbearing potential not using contraception

No

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

No

F.3.3.4

Nursing women

No

F.3.3.5

Emergency situation

No

F.3.3.6

Subjects incapable of giving consent personally

No

F.3.3.7

Others

No

F.4 Planned number of subjects to be included

F.4.1

In the member state

16

F.4.2

For a multinational trial

F.4.2.1

In the EEA

172

F.4.2.2

In the whole clinical trial

360

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned